Application 075806
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NIZATIDINE | NIZATIDINE | CAPSULE;ORAL | 150MG | No | No |
| 002 | NIZATIDINE | NIZATIDINE | CAPSULE;ORAL | 300MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-5150 | Nizatidine | nizatidine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5150 | Nizatidine | nizatidine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5300 | Nizatidine | nizatidine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5300 | Nizatidine | nizatidine | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31022 | ORIG | 2004-06-10 |